Senior Associate, Pharmacovigilance

🔥 0 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

✨ Associate

👻 Ghost score 10%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Lead pharmacovigilance activities for small to moderate-sized clinical studies with support from senior team members • Author Safety Management Plans for assigned studies to support effective safety oversight • Review incoming SAE data for completeness, accuracy, and regulatory compliance • Enter and maintain safety information within safety databases and tracking systems • Generate and manage follow-up queries to resolve missing, incomplete, or unclear safety information • Perform quality control reviews of SAE cases processed by other Pharmacovigilance Associates • Prepare regulatory safety reports and support timely safety submissions • Ensure all pharmacovigilance activities are conducted in accordance with applicable regulations, SOPs, and study-specific requirements • Collaborate with global study teams, internal stakeholders, and external partners

🎯 Requirements

• Bachelor’s degree in a science-related field, nursing, or an equivalent combination of education and relevant experience • Minimum of 1 year of pharmacovigilance experience supporting pre-approval clinical trials • Equivalent combination of relevant education and experience • Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word) • Excellent written and verbal communication skills • Excellent organization skills and attention to detail • Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines • Ability to work independently, prioritize work effectively and work successfully in matrix team environment • Ability and willingness for potential limited travel (domestic and international) as needed • Fluent in written and verbal English

🏖️ Benefits

• Limited domestic and international travel may be required for investigator meetings, project kick-off meetings, and/or bid defense meetings • Equal employment opportunities and an inclusive environment